NCT00292448|CompletedPhase 2

A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Ba 679 BR Respimat® 5 μg and Tiotropium Inhalation Capsule 18 μg in Patients With COPD

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

205.291

Study Type

interventional

Target

157

Locations

1 country

Sites

Timeline

RegisteredFeb 2006

StartedFeb 2006

CompletionMar 2007

Brief Summary

The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

157

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach

1 country

27 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

February 1, 2006

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed

Last Updated

October 29, 2013

Status Verified

October 1, 2013

First QC Date

February 15, 2006

Last Update Submit

October 28, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Secondary Outcomes (1)

Trough FVC response after 4 weeks, peak response (FEV1 and FVC) to first dose, peak response (FEV1 and FVC) after 4 weeks, FEV1 AUC0-3h and FVC AUC0-3h response to first dose and after 4 weeks, individual FEV1and FVC measurements at each time point.

Interventions

Ba 679 BR RespimatDRUG

Tiotropium (Spiriva) inhalation capsule 18 ugDRUG

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: ? Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =\< 70% of predicted normal\* and FEV1 =\< 70% of FVC (Visits 1 and 2). \*: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below). Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005 ? Patients must maintain stable COPD medications for 1 month prior to Visit 1. 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Pack Years = \[Number of cigarettes/ day / 20\] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests. 6\. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler. Patients with/who: 1. Significant diseases except COPD 2. Clinically relevant abnormal haematology, blood chemistry, or urinalysis 3. Recent history of MI 4. Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs 5. Cancer within the last 5 yrs 6. Symptomatic prostatic hypertrophy or bladder neck obstruction 7. Narrow-angle glaucoma 8. History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count \>= 600 mm3 9. History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis 10. Active tuberculosis 11. History of and/or active significant alcohol or drug abuse 12. Underwent thoracotomy with pulmonary resection 13. Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program 14. Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen 15. Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit 16. Beta-blockers 17. Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count \>= 600 mm3 18. Oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone/day or 20 mg every other day 19. Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system 20. Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women 21. Who are currently participating in another study 22. The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Scr. Visit or during the scr. period should be postponed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.